Posted
by
Soulskill
on Tuesday September 27, 2011 @05:27AM
from the not-approved-for-off-label-use dept.

dotarray writes "In what's believed to be an industry first, a developer has begun talks with the American Food and Drug Administration to get its game recognized as a therapeutic drug. 'Brain Plasticity has been fine-tuning a game to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder. Early next year, they will conduct a study with 150 participants at 15 sites across the country. Participants will play the game for one hour, five times a week over a period of six months. If participants' quality of life improves at that "dosage," Brain Plasticity will push ahead with the FDA approval process.'"

I wonder if those exercises your physiotherapist asked you to do after the accident, and if that diet the nutritionist asked to you take to lose some weight, shouldn't also be considered "drugs" and require FDA approval. Jesus how can marketing people be allowed to waste taxpayer funds on a bullshit project like this. I'm not saying the program doesn't work (although it might not - they haven't done real clinical studies yet), I am saying however that dragging the FDA into this is completely irrelevant and a marketing ploy at best.

Somehow I can't take them seriously as "developers" without any sort of company web page. The most you can find is a short entry in a business directory and links to the various copies of the above article.
Did anyone have better luck?

I can't say anything about this company -- I know nothing about it and have never heard about it, but that isn't even remotely uncommon for a small company running dark with nothing to sell. I've done consulting with a number of companies that have gone a year or more like that before having any public visibility, particularly in the healthcare space.

They probably have no interest in selling anything. The rough formula in pharma is:1. Get venture capital based on some promising concept or prior research.2. Develop drug (or in this case video game) using venture capital money3. Do some early studies to see if drug might be effective4. If it looks remotely promising, file with FDA5. IPO!6. Wait for FDA. File. Refile. Watch the stock price jump around like crazy.

At this point, if the FDA approves the drug, they will likely get snatched up by a big company.

If a game can have a medically recognisable affect, it falls under the purview of those who would regulate your private activities for reasons of their morality.

If this is approved, what's the over/under on how long it takes before it is used as a justification for government interference with a tool that is used to bring pleasure in a manner contrary to a morality?

If a game can have a medically recognisable affect, it falls under the purview of those who would regulate your private activities

Most of that crowd is blindly power hungry. Go for common cause with the jocks. Obviously jogging and treadmills have a medical effect and making tennis shoes prescription only or requiring a license to purchase a treadmill will not go over well.

The noteworthy thing appears to be that they are trying to get a full FDA-approved-for-the-treatment-of badge, rather than just generating some modestly positive results and selling it semiformally based on the fact that you have pretty broad latitude when trying potentially theraputic stuff that isn't drugs(which, as you note, has been going on for ages). Because that strategy has already been in use for so long, apparently reasonably successfully, I'm wondering why they are trying this; but it is novel.

Recently, the FDA successfully stopped developers who claimed their programs helped acne (through use of colored display) and had them fined for all their revenue from the apps. These guys are probably just being preemptive.

True, though those devs were slapped down because they were stupid enough to overtly claim specific medical benefits. The FDA can, and sometimes will, slap you down for doing that. However, if your product falls under the DHSEA, you can get away with practically anything, so long as you make your claims in slightly oblique language and don't kill too many people. If it is a food item, you can get away with a similarly broad collection of "Qualified Health Claims". [fda.gov]

So the Food and Drug Administration is now taking its cues from the laughably named "Defense Department" ("Team America World Police" has been a more appropriate name for, at least the lifetime of my parents...) and branching out. Good for them I guess.

It does however make me wonder whether I will be able to play these games without a prescription? Will I be labeled a "recreational player"? Perhaps I should refer to roaming the New Vegas Wasteland as "self medicating"? Will gangs kill each other over the ever escalating prices of black market games? A rash of wild illegal "lan parties" where addicts setup illicit temporary networks.

Eventually they will setup game courts and monitor people to make them kick their habit, which will actually result in a black market for secondary computers that can be hidden inside normal looking furniture.

I am especially looking forward to new forms of "extreme gaming" that will come out of illicit environment. I always thought a game like counterstrike, but where every player's machine was rigged to hit him with a stun gun when he died in game. I imagine that it would quickly change the dynamic of the game and make it quite intense.

It does however make me wonder whether I will be able to play these games without a prescription?

You already can - there's at least one game for the DS3 that purports to exercise the brain. Not to mention that various puzzle books, etc... for "improving the brain and problem solving skills" have been around for decades. On top of that, and also for decades, you've been able to buy children's toys designed to emphasize learning motor skills or various cognitive skills.All without the various over e

The game would not be regulated as a "drug", but rather a "medical device." Software falls in the medical device category.Why might this game be a regulated device? It depends on what the company claims. If the company wants to claim that the game "helps people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder," then it is a medical device used to treat a health condition, and therefore falls under the Food & Drug Act. Before the company coul

I'd be very curious to know what the cost/benefit is for them to seek FDA approval is: Their game has copyright protection even if it is of no theraputic value whatsoever, and games are only ever regulated by Team Morality if they are overtly sexual or violent, so they are totally clear to sell the thing subject only to the generic constraints of trade laws.

Similarly, friends/family/etc. of patients are free to do more or less whatever in the hopes that it might help, assuming it isn't otherwise forbidde

You want to know why basic hearing aids are so damn expensive? Because they're FDA approved. Thus, they can lock-in the price the market will bare. Given how the average citizen is abstracted from the true cost of medical care thanks to medical insurance, the profit margins are astronomical. The supply/demand ratio is way out of tune with normal market forces. Getting a game FDA approved is pure genius. Games are a dime-a-dozen these days. But, get the insurance to cover the expense and you can charge prett

I know somebody who has communications problems. She had the opportunity to purchase some software that would aid her communications (think something like Steven Hawking - but simpler). It ran on a 5-year-old macbook. The whole thing was sold as a bundled package for $10k (yes, with 5 zeros), and was highly locked down (ie no web browsing from the thing, so there would be no possible synergies using it to type emails or something).

The only reason they can get away with it is that insurance would pay most

Considering this "game" is targeted at schizophrenics I doubt anyone is going to be playing it too much. Now getting people to stop trying to destroy the monitor because the voices told them that it had demons inside, yeah, that could be a problem. But playing it too much no, I will give you 5 reasons... 1. Morning is green bicycles on my chair, 2. That shirt is pissing me off because of my dog and (insert long, disjointed schizophrenic rant).

"...to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder..."

So they're going to take crazy people and try to make them smarter and more focused without trying to address the craziness. Is anyone worried about this? Do we really need more Hannibal Lecters in this world? (Part joke, part serious.)

In theory, this isn't actually that out-there as an addition to a treatment regimen, although the trial should be an order of magnitude larger to produce meaningful data. What we'd hope for is a means of giving the patient a quantifiable, self-directed method of practicing certain aspects of his or her cognitive behavioral therapy -- there's a lot more to therapy than what takes place at the therapist's office. The danger comes from a product that allows the patient to learn to beat the game, rather than im